Safety and Efficacy of the Early Introduction of Everolimus (Certican®) With Low Dose of Cyclosporine in de Novo Kidney Recipients After 1 Month of Transplantation
Everolimus + Low dose CsA +PD
+ Myfortic+ Standard CsA + PD
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 2009
Fecha en la que se inscribió al primer participante.Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection episodes of cadaveric allograft recipients. Although marked progression has been made in initial survival rates, long-term kidney graft survival has yet to show such encouraging results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which contribute to declining organ function and eventual graft loss. In kidney transplants, progressive allograft dysfunction has been shown to develop in as many as 94% of patients by 1 year. Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be balanced against the maintenance of adequate immunosuppression. Certican allows CNI dose reduction then provides renal function improvement and current PSI strategy point out that early intervention is important in managing the risk of CAN before it develops in both de novo and maintenance renal transplant recipients. To demonstrate Certican early introduction after 1 month provides better renal function with no change of efficacy compared to standard regimen, and also prevent delayed wound healing.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: Males or Females aged 18~65 years De novo recipients of cadaveric, living unrelated or living related donor kidney transplants Received kidney transplant from aged 10~65years donor Willing to provide written informed consent Completing study visits according to study protocol Exclusion Criteria: Recipients of multiple organ transplants Kidney transplant from non-heart beating cadaveric donor / organ donor after cardiac death Recipients of A-B-O incompatible transplants or lymphocyte cross-match positive transplants Recipients of extra-renal solid organ transplants or stem cell transplants Recipient/ donor who are known to have anti-HCV, HIV or HBsAg positive Diagnosed as Cancer within the past 5 years (except complete recovered squamous cell or basal cell skin cancer) Drug Hypersensitivity to investigational drugs or related drugs Females are pregnant and lactating Any of the following laboratory abnormalities at screening: ALT, AST, ALP, total bilirubin > 3 times the upper limit ANC < 1,500mm3 or WBC < 2,500mm3 or platelet < 100,000 mm3 Cholesterol > 350 mg/dl or 9.0 mmol/L, TG > 500 mg/dl or 5.6mmol/L
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Department of Surgery, Yonsei University College of Medicine, Severance Hospital
Seoul, South KoreaAbrir Department of Surgery, Yonsei University College of Medicine, Severance Hospital en Google Maps